Flexible port seal

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/161,833 filed on Mar. 20, 2009, the entire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to a flexible port seal for use in single incision surgical procedures. More particularly, the present disclosure relates to a flexible port seal having multiple, independently movable throughports.

2. Background of Related Art

Methods and apparatus for performing closed surgical procedures are known. Such procedures greatly reduce postoperative recovery time and minimize scarring to the patient. These procedures typically involve inserting one or more access assemblies through the abdominal wall of the patient and insufflating the abdominal cavity. A laparoscope or other viewing instrument is inserted through one of the access assemblies, or directly through the abdominal wall, to provide the clinician with an image of the abdominal cavity. The surgeon is then able to perform the procedure within the abdominal cavity by manipulating instruments that have been extended through the access assemblies.

The number and type of instruments that a surgeon may use to complete a closed procedure is limited by the number, size and configuration of the access assemblies that have been inserted into the abdominal cavity. Because traditional access assemblies are configured to provide access for only a single instrument, the simultaneous use of any additional instruments requires a corresponding access assembly. For each additional access assembly necessary to complete the procedure, an additional incision must be created. Each additional incision increases the length of the procedure and may prolong post-operative recovery time.

Therefore, it is desirable to provide an access assembly for insertion through a single incision in the body of a patient which provides multiple ports for receipt of one or more surgical instruments.

SUMMARY

There is disclosed a flexible port seal for insertion through tissue. The flexible port seal generally includes an outer seal having a proximal end and a distal end and defines a bore extending from the proximal end of the outer seal to the distal end of the outer seal. A support plate is located within the bore of the outer seal and a throughport extends through the support plate. The throughport defines a bore for receipt of a surgical instrument such that the throughport forms a fluid tight seal against a surgical instrument inserted through the throughport. In an embodiment, the surgical instrument inserted through the throughport is a cannula. Such a cannula may be configured to receive other instrumentation therethrough, e.g., clip appliers, graspers, dissectors, retractors, staplers, laser probes, photogenic devices, endoscopes and laparoscopes, tubes and the like. Alternatively, the throughport may be configured to receive such other instruments directly therethrough, e.g., without requiring a cannula to be inserted first. For the purposes of this application, the terms “instruments or instrumentation” will refer to collectively to a cannula or any of the other types of instrumentation.

The outer seal has a central portion and an upper rim at a proximal end of the central portion. The outer seal also has a lower rim at a distal end of the central portion. The upper and lower rims have a diameter greater than the diameter of the central portion.

In an embodiment, the outer seal has a groove formed in an inner surface of the outer seal for receipt of the support plate. An outer edge of the support plate is positioned within the groove formed in the inner surface of the outer seal. In a specific embodiment, the support plate is a circular disk. In an alternative embodiment, the support plate is formed integrally with the outer seal.

The support plate may include an opening such that an outer surface of the throughport forms a fluid tight seal with the opening when the throughport is positioned through the opening. Alternatively, the support plate, the outer seal and the throughport are all formed integrally with each other.

In an embodiment, the throughport is a hollow tube extending through the support plate. The throughport may include an instrument seal located within a bore of the hollow tube. In one specific embodiment, the instrument seal is an hourglass seal. In an alternative specific embodiment, the instrument seal is a duckbill valve.

In various specific embodiments, the outer seal is formed of a flexible material, the support plate is formed of a flexible material and/or the throughport is formed of a flexible material.

There is also disclosed a flexible port seal for insertion through tissue including an outer seal having a proximal end and a distal end. The outer seal is formed of a flexible material and defines a bore extending from the proximal end of the outer seal to the distal end of the outer seal. A support plate is integrally formed therewith of the flexible material and is located within the bore of the outer seal. A plurality of throughports are provided, e.g., integrally formed therewith, and may extend through the support plate and define throughbores for receipt of cannulas and/or surgical instruments therethrough.

In an embodiment, instrument seals are formed within each of the throughports such that the instrument seals form fluid tight seals against surgical instruments inserted through the throughbores of the throughports. In one specific embodiment, the instrument seals are hourglass seals. In an alternative specific embodiment, the instrument seals are duckbill valve type seals. Still further, the throughports may be hollow tubes without seals.

DESCRIPTION OF THE DRAWINGS

An embodiment of the presently disclosed flexible port seal is disclosed herein with reference to the drawings, wherein:

<figref idrefs="DRAWINGS">FIG. 1</figref> is a perspective view of the disclosed flexible port seal;

<figref idrefs="DRAWINGS">FIG. 2</figref> is a top view of the flexible port seal of <figref idrefs="DRAWINGS">FIG. 1</figref>;

<figref idrefs="DRAWINGS">FIG. 3</figref> is a side view of the flexible port seal of <figref idrefs="DRAWINGS">FIG. 1</figref> with a plurality of inner throughports and a support disk shown in phantom;

<figref idrefs="DRAWINGS">FIG. 4</figref> is a perspective view, partially shown in section, of the flexible port seal of <figref idrefs="DRAWINGS">FIG. 1</figref>;

<figref idrefs="DRAWINGS">FIG. 5</figref> is a perspective view, partially shown in section, of a flexible port seal with separable parts;

<figref idrefs="DRAWINGS">FIG. 6</figref> is a side view, shown in section, of one embodiment of an inner throughport;

<figref idrefs="DRAWINGS">FIG. 7</figref> is a top view of the inner throughport of <figref idrefs="DRAWINGS">FIG. 6</figref>;

<figref idrefs="DRAWINGS">FIG. 8</figref> is a side view, shown in section, of an alternative embodiment of an inner throughport;

<figref idrefs="DRAWINGS">FIG. 9</figref> is a top view of the inner throughport of <figref idrefs="DRAWINGS">FIG. 8</figref>;

<figref idrefs="DRAWINGS">FIG. 10</figref> is a perspective view of a tissue section having an incision therethrough with an underlying body organ shown in phantom;

<figref idrefs="DRAWINGS">FIG. 11</figref> is a perspective view of the flexible port seal of <figref idrefs="DRAWINGS">FIG. 1</figref> prepared for insertion through the incision in the tissue;

<figref idrefs="DRAWINGS">FIG. 12</figref> is a perspective view of the flexible port seal of <figref idrefs="DRAWINGS">FIG. 1</figref> positioned through the incision in the tissue;

<figref idrefs="DRAWINGS">FIG. 13</figref> is a side view, partially shown in section, of the flexible port seal of <figref idrefs="DRAWINGS">FIG. 1</figref>, with cannula ports and surgical instruments inserted therethrough and positioned above the body organ;

<figref idrefs="DRAWINGS">FIG. 14</figref> is a side view, partially shown in section, of an inner throughport with a cannula and surgical instrument inserted therethrough; and

<figref idrefs="DRAWINGS">FIG. 15</figref> is a side view, partially shown in section, of an outer seal of the flexible port seal positioned through the tissue and a surgical instrument positioned to perform a surgical procedure, according to an embodiment.

DETAILED DESCRIPTION

An embodiment of the presently disclosed flexible port seal will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term “proximal” refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to that part or component further away from the user.

Referring to <figref idrefs="DRAWINGS">FIGS. 1-3</figref>, there is disclosed a flexible port seal <b>10</b> for use in single incision surgery. Flexible port seal <b>10</b> is flexible or compressible to allow it to be inserted through a single incision in the body of a patient such that after insertion it will expand and seal within the incision. Additionally, the flexible nature of flexible port seal <b>10</b> allows surgical instruments inserted therethrough to be manipulated relative to their respective axes and thus allows a relatively high degree of movement of the surgical instruments to orient them appropriate to the tissue being operated upon.

Flexible port seal <b>10</b> generally includes an outer tissue seal <b>12</b> having one or more throughports <b>14</b>, <b>16</b> and <b>18</b> extending therethrough. Throughports <b>14</b>, <b>16</b> and <b>18</b> are provided to receive various surgical cannulas and/or instruments therethrough. The close proximity of throughports <b>14</b>, <b>16</b> and <b>18</b> allows for unrestricted, independent movement of the surgical instruments inserted therethrough. As best shown in <figref idrefs="DRAWINGS">FIGS. 2 and 3</figref>, a central support plate or disk <b>20</b> is provided to support throughports <b>14</b>, <b>16</b> and <b>18</b> within outer tissue seal <b>12</b>.

Outer tissue seal <b>12</b> and central support disk <b>20</b> are formed from a flexible material which, as noted hereinabove, allows flexible port seal <b>10</b> to be compressed and inserted through an incision in the body of a patient as well as allowing for independent movement of throughports <b>14</b>, <b>16</b> and <b>18</b> extending through support disk <b>20</b>. Outer tissue seal <b>12</b> and support disk <b>20</b> may be formed of various materials such as, for example, silicone, thermoplastic elastomers, rubber, foam, gel, etc. Where desired, throughports <b>14</b>, <b>16</b> and <b>18</b> may also be formed from various flexible materials and may be integrally formed therewith.

With continued reference to <figref idrefs="DRAWINGS">FIGS. 1-3</figref>, outer tissue seal <b>12</b> includes a central portion <b>22</b> having an upper rim <b>24</b> located at a proximal end <b>26</b> of central portion <b>22</b>. A lower rim <b>28</b> is located on a distal end <b>30</b> of central portion <b>22</b>. Upper rim <b>24</b> and lower rim <b>28</b> aid in preventing movement of flexible port seal <b>10</b> longitudinally through the incision in the patient.

With specific reference to <figref idrefs="DRAWINGS">FIG. 3</figref>, throughports <b>14</b>, <b>16</b> and <b>18</b> may be attached to, e.g., integrally formed with and/or extend through, outer tissue seal <b>12</b> from a proximal end <b>32</b> of outer tissue seal <b>12</b> to a distal end <b>34</b> of outer tissue seal <b>12</b>. It should be recognized that throughports <b>14</b>, <b>16</b> and <b>18</b> may have different lengths as compared to each other, and may respectively extend in either direction for any distance relative to the support disk <b>20</b>. For example, any one or more of the throughports <b>14</b>, <b>16</b>, <b>18</b> may extend beyond the proximal end <b>32</b> of outer tissue seal <b>12</b> or may extend to less than the proximal end <b>32</b> of the outer tissue seal <b>12</b>, e.g., including not extending at all from the support disk <b>20</b>. Also, any one or more of the throughports <b>14</b>, <b>16</b>, <b>18</b> may extend beyond the distal end <b>34</b> of outer tissue seal <b>12</b> or may extend to less than the distal end <b>34</b> of the outer tissue seal <b>12</b>, e.g., including not extending at all from the support disk <b>20</b>. These differences in lengths may allow the flexible port seal <b>10</b> to be more easily compressed prior to insertion within an incision. Furthermore, these differences in lengths may allow the flexible port seal <b>10</b> to accommodate different types of surgical instrumentation, different surgical procedures, etc.

Referring back to <figref idrefs="DRAWINGS">FIG. 2</figref>, throughports <b>14</b>, <b>16</b> and <b>18</b> include respective throughbores <b>36</b>, <b>38</b> and <b>40</b> for receipt of surgical cannulas and/or instruments in a manner described in more detail hereinbelow.

Referring now to <figref idrefs="DRAWINGS">FIGS. 4 and 5</figref>, as noted hereinabove central support disk <b>20</b> is provided within outer tissue seal <b>12</b> to support throughports <b>14</b>, <b>16</b>, and <b>18</b>, within outer tissue seal <b>12</b>. Central support disk <b>20</b> may be formed integrally with outer tissue seal <b>12</b> or may be provided as a separate component. When provided as a separate component, a groove <b>42</b> may be formed about an inner surface <b>44</b> of central portion <b>22</b> of central support disk <b>20</b>. Alternatively, groove <b>42</b> may be provided at other locations within outer tissue seal <b>12</b>. Upon assembly, a circumferential edge <b>46</b> of central support disk <b>20</b> fits within groove <b>42</b> by any type of mechanical connection, e.g., in friction fit fashion, such that circumferential edge <b>46</b> forms a fluid tight seal within groove <b>42</b>.

In an embodiment, central support disk <b>20</b> is provided with a plurality of holes <b>48</b>, <b>50</b> and <b>52</b> for receipt of throughports <b>14</b>, <b>16</b> and <b>18</b>, respectively. When positioned therethrough, outer surfaces <b>54</b>, <b>56</b> and <b>58</b> of throughports <b>14</b>, <b>16</b> and <b>18</b>, respectively, foam fluid tight seals with holes <b>48</b>, <b>50</b> and <b>52</b>. It should also be noted that, due to the flexible nature of central support disk <b>20</b> and relatively small longitudinal contact area of central support disk <b>20</b> with throughports <b>14</b>, <b>16</b> and <b>18</b>, throughports <b>14</b>, <b>16</b> and <b>18</b> are free to flex relative to central support disk <b>20</b> to allow for independent movement of surgical cannulas and/or instruments inserted through throughports <b>14</b>, <b>16</b> and <b>18</b> in a manner described in more detail hereinbelow.

Referring now to <figref idrefs="DRAWINGS">FIGS. 6 and 7</figref>, there is shown an embodiment in which the throughports <b>14</b>, <b>16</b> and <b>18</b> are configured to seal directly with an instrument inserted therein, e.g., without the need for a cannula to be inserted first. In this embodiment, in order to provide a fluid tight seal between throughports <b>14</b>, <b>16</b> and <b>18</b>, for example throughport <b>14</b> shown here, and a surgical instrument inserted therethrough, throughport <b>14</b> is provided with an internal instrument seal. In this embodiment, the disclosed instrument seal is an hourglass type valve or seal <b>60</b> formed on an inner surface <b>62</b> of throughport <b>14</b> and defining a central opening or passageway <b>64</b> for receipt of a surgical instrument therethrough. Thus, as a surgical instrument is inserted through a proximal end <b>66</b> of throughport <b>14</b> it passes through and seals within central opening <b>64</b> and extends out of a distal end <b>68</b> of throughport <b>14</b>.

Likewise, referring to <figref idrefs="DRAWINGS">FIGS. 8 and 9</figref>, in an alternative embodiment, the instrument seal provided within throughport <b>14</b> is a duckbill valve type seal <b>70</b> having a pair of flaps <b>72</b> and <b>74</b> extending from inner surface <b>62</b> of throughport <b>14</b>. Distal ends <b>76</b> and <b>78</b> of flaps <b>72</b> and <b>74</b>, respectively, define a slot <b>80</b> therebetween for sealing receipt of a surgical instrument there through. Similar to hourglass seal <b>60</b> described hereinabove, once a surgical instrument is inserted into proximal end <b>66</b> of throughport <b>14</b> it passes through and seals within slot <b>80</b> and extends out of distal end <b>68</b> of throughport <b>14</b>.

It should be noted that, while the disclosed instrument seals formed within throughport <b>14</b> have been illustrated as an hourglass seal <b>60</b> (<figref idrefs="DRAWINGS">FIGS. 6 and 7</figref>) or a duckbill valve type seal <b>70</b> (<figref idrefs="DRAWINGS">FIGS. 8 and 9</figref>), other types of seals may be provided within throughports <b>14</b>, <b>16</b> and <b>18</b> to seal about surgical instruments inserted therethrough. Furthermore, depending upon the nature of the surgical instruments to be used through throughports <b>14</b>, <b>16</b> and <b>18</b>, the instrument seals provided within throughports <b>14</b>, <b>16</b>, and <b>18</b> need not be identical and, in certain circumstances, may differ from each other.

Referring now to <figref idrefs="DRAWINGS">FIGS. 10-15</figref>, and initially with regard to <figref idrefs="DRAWINGS">FIGS. 10 and 11</figref>, the use of flexible port seal <b>10</b> in a single incision surgical procedure to perform a surgical procedure will now be described. The procedure discussed hereinbelow may be any type of surgical procedure, and is described as a procedure to excise and remove a body organ for illustrative purposes only. Initially, a single incision I is formed through a body tissue T and above a body organ, such as, for example, kidney K. In this surgical procedure it is desirable to operate on, and remove, kidney K with multiple surgical instruments while forming only a single incision I through body tissue T. With specific reference to <figref idrefs="DRAWINGS">FIG. 11</figref>, once incision I has been foamed through body tissue T, flexible port seal <b>10</b> may be squeezed or compressed to reduce it to a relatively smaller diameter for insertion through incision I. As noted hereinabove, outer tissue seal <b>12</b> is formed of flexible material which allows flexible port seal <b>10</b> to be compressed.

Referring to <figref idrefs="DRAWINGS">FIG. 12</figref>, once flexible port seal <b>10</b> has been inserted through incision I pressure on the outer tissue seal <b>12</b> can be released allowing outer tissue seal <b>12</b> to return to its initial uncompressed state within incision I. As noted hereinabove, outer tissue seal <b>12</b> includes upper rim <b>24</b> and lower rim <b>28</b>. Upper and lower rims <b>24</b> and <b>28</b>, respectively, are provided to prevent migration of flexible port seal <b>10</b> through incision I in body tissue T. Once flexible port seal <b>10</b> has been positioned above kidney K, various surgical instruments may be inserted through throughports <b>14</b>, <b>16</b> and <b>18</b> to operate on kidney K.

With specific reference to <figref idrefs="DRAWINGS">FIG. 13</figref>, as shown, surgical instrumentation, such as, for example, conventional cannulas <b>82</b>, <b>84</b> and <b>86</b> may be inserted through throughports <b>14</b>, <b>16</b> and <b>18</b>. Cannulas <b>82</b>, <b>84</b> and <b>86</b> include respective housings <b>88</b>, <b>90</b> and <b>92</b>. Housings <b>88</b>, <b>90</b> and <b>92</b> include respective access tubes <b>94</b>, <b>96</b> and <b>98</b> extending distally from housings <b>88</b>, <b>90</b> and <b>92</b>. With reference to cannula <b>86</b>, for example, housing <b>92</b> of cannula <b>86</b> may be provided with an insufflation port <b>100</b> which is connected to a source of insufflation fluid to insufflate the area and within the body beneath tissue T and about kidney K. Alternatively, the flexible port seal <b>10</b> may have additional tubes, ports or connections (not shown) that separately operate to connect to and provide insufflation fluid or to provide smoke evacuation if desired. Once the body has been properly insufflated, kidney K may be operated upon to excise it from the surrounding tissue.

Referring for the moment to <figref idrefs="DRAWINGS">FIG. 14</figref>, throughport <b>18</b> is illustrated with cannula <b>86</b> inserted therethrough. Specifically, access tube <b>98</b> is inserted through throughport <b>18</b>. As illustrated, throughport <b>18</b> is provided with an instrument seal, such as, for example hourglass seal <b>60</b> which forms a fluid tight seal around access tube <b>98</b> inserted therethrough. Alternatively, the cannula <b>86</b> may be selected so as to have a tight fit within the throughbore of the throughport <b>18</b>, thereby eliminating the need to have an instrument seal within the throughbore of the throughport <b>18</b>. Also, the cannula <b>86</b> may include any type of fixation element, e.g., external threads, ribs, locking mechanisms, etc., that help maintain the cannula in position and help maintain the seal between the surface of the cannula <b>86</b> and the inner surface of the throughport <b>18</b>.

Once cannula <b>86</b> has been properly inserted through throughport <b>18</b>, a surgical instrument <b>102</b> may be inserted through cannula <b>86</b> to perform surgical operations on underlying tissue. Surgical instrument <b>102</b> includes a handle <b>104</b> having an elongate tubular member <b>106</b> extending distally from handle <b>104</b>. Specifically, elongate tubular member <b>106</b> is inserted through a proximal opening <b>108</b> in housing <b>92</b> of cannula <b>86</b> such that a distal end of <b>110</b> of elongate tubular member <b>106</b> projects from a distal end <b>112</b> of access tube <b>98</b> of cannula <b>86</b>. In this manner surgical instrument <b>102</b> may be positioned within the body to perform surgical operations on underlying tissue.

As noted hereinabove, central support disk <b>20</b> (<figref idrefs="DRAWINGS">FIG. 4</figref>) forms a fluid tight seal about throughport <b>18</b> at a relatively small contact area B with throughport <b>18</b>. As shown in <figref idrefs="DRAWINGS">FIG. 14</figref>, throughport <b>18</b> defines a longitudinal axis A-A which coincides with the longitudinal axes of cannula <b>86</b> and surgical instrument <b>102</b> inserted therethrough. Due to the flexible nature of the throughport <b>18</b> and/or central support disk <b>20</b>, throughport <b>18</b> may be flexed off-axis by manipulation of surgical instrument <b>102</b> and/or cannula <b>86</b> to reorient surgical instrument <b>102</b> along a flexed or offset axis A′-A′. This allows the surgeon to manipulate or orient surgical instrument <b>102</b> at various locations relative to the tissue being operated upon.

Referring now to <figref idrefs="DRAWINGS">FIG. 15</figref>, once surgical instrument <b>102</b> has been utilized to operate on underlying kidney K to excise or sever kidney K for harvesting, cannulas <b>80</b> to <b>84</b> and <b>86</b> may be removed from flexible port seal <b>10</b> and flexible port seal <b>10</b> withdrawn from incision I. Thereafter, a separate surgical instrument may be utilized to remove the excised kidney K from the body. Alternatively, where outer tissue seal <b>12</b> and central support disk <b>20</b> are formed as separate components, central support disk <b>20</b> can be removed from within outer tissue seal <b>12</b> leaving outer tissue seal <b>12</b> extending through incision I. In this situation, outer tissue seal <b>12</b> functions as a relatively large access port through tissue T. A surgical instrument, such as, for example, surgical instrument <b>102</b>, may be inserted through outer tissue seal <b>12</b> and manipulated such that an end effector <b>114</b>, positioned on distal end <b>110</b> of access tube <b>98</b>, is utilized to grasp kidney K and withdraw kidney K from within the body and through outer tissue seal <b>12</b>. Alternatively, the entire flexible port seal <b>10</b> may be removed from the incision prior to withdrawing the kidney K through the incision.

Once kidney K has been removed from the body, the single incision I can be closed in a conventional manner. Thus, flexible port seal <b>10</b> provides multiple, independently movable instrument access ports through a single incision in the patient's body.

It will be understood that various modifications may be made to the embodiments disclosed herein. For example, as noted hereinabove, the disclosed throughports may also be formed of flexible materials to allow for the use of articulating surgical instruments therethrough. Further, the disclosed flexible port seal may be provided with multiple throughports in excess of the disclosed three throughports. Additionally, the lengths and diameters of the disclosed throughports need not be identical but may be varied depending upon the contemplated surgical instrumentation to be utilized therethrough. Still further, the throughports need not be straight as shown, but any one or more may be curved, bent, or have any other shape suitable to receive a particular surgical instrument. Also, while the support disk is shown as being relatively straight, thin and having a relatively constant thickness, the support disk may be curved or contoured, may be thicker if desired and/or may have varying thicknesses over its area, e.g., to improve its flexibility, to improve its sealing capabilities, to improve its resistance to tearing when manipulated. In addition, while the support disk is shown as being located at approximately a longitudinal midpoint of the flexible port seal, it may instead be located at any location between the proximal and distal ends of the flexible port seal. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.